Clinical Trials Directory

Trials / Completed

CompletedNCT02831621

Exercise and Ectopic Fat Deposition

Effect of Diet Plus Exercise Versus Diet Alone on the Reduction of Ectopic Fat Deposition in Adults With Overweight

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Universiteit Antwerpen · Academic / Other
Sex
Female
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

Excess ectopic fat deposition is associated with development of cardiovascular and metabolic diseases. This study investigates how lifestyle interventions can have an effect on different sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the clinical and economic value of exercise to supplement a hypocaloric diet is investigated. Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women during consultations. Also, recruitment posters will be used in the University Hospital of Antwerp and the University of Antwerp. Potential participants meeting all a priori set inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric diet group (usual care) or a group of hypocaloric diet combined with physical fitness training. Both groups will undergo an intake procedure in which personal goals are set and barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by imaging techniques after three and six months of intervention. Based on the known relationship between ectopic fat and cardiovascular outcomes, the short term study results will then be extrapolated to an estimation of the reduction of cardiovascular events. The following clinical outcomes will be presented: change in ectopic fat in the abdomen (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids), heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The impact of supervised exercise in addition to diet will be expressed in projected healthcare costs and quality adjusted life years.

Detailed description

protocol of the study was published, Hens et al. (physioscience 2017; 13: 80-87)

Conditions

Interventions

TypeNameDescription
BEHAVIORALlifestyle intervention (diet OR diet+exercise)diet or diet+fitness training

Timeline

Start date
2016-06-01
Primary completion
2017-08-01
Completion
2019-01-01
First posted
2016-07-13
Last updated
2019-01-25

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02831621. Inclusion in this directory is not an endorsement.